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Completed

NCT Number: NCT01058083

Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypercholesterolemia
  • Currently taking a stable daily dose of statin therapy
  • Serum triglyceride level < 500mg/dl

Exclusion criteria

  • History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
  • Congestive heart failure
  • Diabetes mellitus
  • Active liver disease
  • Impaired renal function
  • Hepatitis C, B and HIV

This list is not inclusive additional information is provided in the protocol

Treatment and study plan

BMS-770767

Drug

Active, Oral, 15 mg, Daily, 28 days

Placebo

Drug

Placebo, Oral, 0 mg, daily, 28 days

Primary outcomes

  1. Lowering of LDL-C

    Time frame: Within 28 days following dosing

Secondary outcomes

  1. Pharmacokinetics (Blood Level) of BMS-770767

    Time frame: Within 28 days following dosing

  2. Pharmacodynamic effects of BMS-770767 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, non-esterified free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)

    Time frame: Within 28 days following dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Double-blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Primary Hypercholesterolemia

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 28, 2010
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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